Introducer system and assembly for surgical staplers
An introducer assembly for use with a surgical stapler is provided. The introducer assembly includes an elongated main body portion, one or more mounting mechanisms associated with the main body portion, and a plurality of petals or fingers positioned at a distal end of the elongated main body portion. The one or more mounting mechanisms are adapted to detachably mount with respect to the surgical stapler. The plurality of petals or fingers define a distal junction and a proximally-directed mounting member that is adapted to detachably engage a distal portion of the surgical stapler. The plurality of petals or fingers define an inner region that accommodates a distal end of the surgical stapler. The distal junction and the proximally-directed mounting member associated with the plurality of petals or fingers are adapted to disengage upon application of a requisite proximally-directed force to the elongated body portion. Methods and combinations that utilize the introducer are also disclosed.
1. Technical Field
The present disclosure is directed to a system/assembly for facilitating introduction and/or positioning of a surgical stapler at or to a desired anatomical location. More particularly, the present disclosure is directed to an introducer system/assembly that is adapted to be detachably mounted with respect to a surgical stapler, e.g., an end-to-end or end-to-side anastomotic stapler.
2. Background Art
Wound closure techniques include the use of surgical staplers and clip appliers in many clinical applications. Surgical staplers and clip appliers take many forms and are adapted for use in various modalities. Thus, for example, certain staplers are specifically designed for application of skin staples, while others are adapted for use in internal procedures. Indeed, surgical staplers and clip appliers have been developed and are employed in both “open” and “minimally invasive” surgical procedures.
One particular form of surgical stapler having a specialized design and specialized uses is a circular stapler for use in performing end-to-end and end-to-side anastomotic procedures, e.g., the EEA™ line of staplers (Covidien, Inc., Mansfield, Mass.). The noted circular staplers generally take the form of a tubular instrument that defines a tubular shaft at a distal end thereof. A disposable cartridge is generally adapted to be mounted with respect to tubular shaft, such cartridge containing two or more circular rows of staggered staples, pushers for driving the staples from the cartridge and a circular knife within the inner ring of staples. An anvil assembly is adapted to mount with respect to a distally extending rod such that, when the anvil assembly is brought into close juxtaposition with the staple cartridge, the staples may be discharged from the cartridge and formed against anvil pockets defined in the anvil assembly. In addition, the anvil assembly also generally includes a plastic ring into which the circular knife is driven during the stapling operation. A control mechanism is provided at the proximal end of the surgical stapler to control relative movement between the staple cartridge and the anvil assembly. Once approximated, an actuating mechanism at the proximal end of the surgical stapler is employed to deliver staples into tissue and advance the circular knife into the plastic ring, thereby forming an anastomotic junction.
Circular staplers of the type described above are generally employed in esophageal and rectal procedures, although the staplers have utility throughout the gastrointestinal tract. For example, in bowel surgeries, purse-stringed bowel segments to be anastomosed are passed over the anvil assembly—which is typically dome-shaped—and the staple cartridge, respectively, and the purse-strings tightened around the central shaft. The anvil assembly and staple cartridge are then approximated and upon actuation of the actuating mechanism, an instantaneous, minimally-inverting, end-to-end or end-to-side anastomosis is effectuated. The circular stapler may be introduced and positioned through a natural orifice, e.g., the anus (e.g., a low anterior resection of the rectum) or the mouth (e.g., high esophago-gastric anastomosis). Alternatively, the circular stapler can be introduced through an opening formed during a procedure, e.g., in the stomach for esophagogastrostomy, in the small bowel for esophagojejunostomy, the terminal ileum for esophagocecostomy, and the like.
Of note, introduction and positioning of a circular stapler can be difficult in practice due to the physical structures associated with the distal end of the stapler. In particular, the stapler cartridge generally defines a substantially flat surface that is to be advanced through the intestinal tract or other anatomical lumen. Indeed, challenges exist in introducing a substantially flat surface into an orifice and thereafter advancing such flat surface through the lumen, e.g., up into the rectum, potentially encountering redundancies to the colon, redundant mucosa and/or prominent valves. Difficulties in introducing a surgical stapler and/or positioning the surgical stapler in a desired anatomical location can inhibit its successful use.
Prior art efforts to address the above-noted issues have been less than satisfactory. Thus, for example, U.S. Pat. No. 5,404,870 to Brinkerhoff et al., U.S. Pat. No. 5,836,503 to Ehrenfels et al., and U.S. Patent Publication No. 2005/0165438 to Gritsus disclose devices and/or geometries that are intended to facilitate introduction and/or positioning of surgical staplers. Additional patent-related publications of background interest include U.S. Pat. Nos. 7,318,830; 5,355,897; 5,314,436; 4,471,782; 3,672,367; and 2,007,626, as well as U.S. Patent Publication No. 2005/0236459.
However, despite efforts to date, a need remains for introducer systems and assemblies that facilitate introduction and positioning of a surgical stapler relative to a desired anatomical location. A need further remains for introducer systems and assemblies that are adapted for easy and reliable detachment from the surgical stapler once its introduction and/or positioning functionalities are complete. These and other needs are satisfied by the introducer systems and assemblies disclosed herein.
SUMMARYAccording to the present disclosure, an advantageous device, assembly and method are provided for facilitating introduction and/or positioning of a surgical stapler relative to a desired anatomical location. The disclosed device/assembly takes the form of a “tear-away” introducer that is adapted to be detachably mounted with respect to the surgical stapler. In exemplary embodiments, the disclosed introducer includes a distal component that defines a plurality “petals” or “fingers” that (i) come together in a mounting member at their distal end, and (ii) cooperate with an elongated body portion at their proximal end. The petals/fingers define an inner region that is configured and dimensioned to accommodate the distal end of a surgical stapler, thereby facilitating anatomical introduction of the circular stapler. The elongated main body portion of the disclosed introducer defines mounting mechanism(s), e.g., “C-shaped” mounting brackets, that are adapted to detachably engage the outer surface/shaft of the surgical stapler.
In an exemplary embodiment, the disclosed introducer is generally mounted with respect to a surgical stapler with the distal mounting member positioned relative to a distal component of the surgical stapler. The mounting mechanisms, e.g., C-shaped brackets of the introducer, detachably engage the stapler shaft. In advancing the surgical stapler to the desired stapling site, the petals/fingers of the introducer help to guide the stapler past potential obstructions and/or anatomical irregularities. Thereafter, the introducer is adapted to be detached from the stapler by pulling proximally on the elongated body portion, causing the petals/fingers to “tear away” from around the distal portion of the surgical stapler, thereby facilitating removal from the stapler.
In an alternative embodiment, the disclosed introducer may include or cooperate with one or more intermediate structures, e.g., extension member(s). For example, one or more intermediate structures may be positioned between the disclosed petals/fingers and the elongated body portion. Of note, the intermediate structure(s) may include structural features and/or functionalities that facilitate interaction with a surgical stapler, e.g., mounting mechanism(s) for detachably securing the disclosed introducer with respect to a surgical stapler.
Additional features, functions and benefits of the disclosed introducer device/assembly will be apparent from the figures which follow, particularly when viewed in conjunction with the accompanying description.
To assist those of ordinary skill in the art in making and using the introducer device and assembly of the present disclosure, reference is made to the accompanying figures, wherein:
The disclosed devices, assemblies and methods advantageously facilitate introduction and/or positioning of a surgical stapler relative to a desired anatomical location. In addition, the disclosed devices, assemblies and methods permit a user to remotely detach the device/assembly from the surgical stapler, thereby permitting unobstructed operation of the surgical stapler in a desired manner. The disclosed devices, assemblies and methods also permit a user to extend the shaft of the surgical stapler, thereby permitting the surgical stapler to reach anatomical locations that otherwise may be hard to reach, while facilitating the introduction and/or positioning of the surgical stapler to these locations. The disclosed devices, assemblies and methods have wide ranging applicability and utility, including specifically applications throughout the gastrointestinal tract.
With initial reference to
One or more mounting mechanisms are generally provided along the length of the main body portion 16 of the introducer 10 to facilitate detachable mounting of introducer 10 relative to a surgical stapler. Thus, in the exemplary embodiment of
With further reference to
In an alternative embodiment, the disclosed introducer 10 may include or cooperate with one or more intermediate structures, e.g., extension member(s) (not pictured). For example, one or more intermediate structures may be positioned between the disclosed petals/fingers 20 and the main body portion 16, e.g., such that the petals/fingers 20 are mounted with respect to the intermediate structure(s). Of note, the intermediate structure(s) may include structural features and/or functionalities that facilitate interaction with a surgical stapler, e.g., mounting mechanism(s) for detachably securing the disclosed introducer with respect to a surgical stapler.
In exemplary embodiments of the present disclosure, mounting member 26 defines a central channel that is configured and dimensioned to receive a distally-directed shaft member extending from the surgical stapler. Alternatively, mounting member 26 may define a rod-like structure that is configured and dimensioned for receipt in a distally-directed channel associated with the surgical stapler. In any case, mounting member 26 is adapted to detachably secure the distal end of introducer 10 with respect to the distal end of a surgical stapler. Various techniques may be employed to combine the plurality of petals/fingers 20 at distal junction 24 and to define mounting member 26 therefrom. For example, the petals/fingers 20 may be adhered with respect to each other using conventional adhesives. Alternatively, one or more banding members may be positioned around the petals/fingers 20 in the vicinity of distal junction 24 and/or the proximally-directed mounting member 26. Additionally, the plurality of petals may be mounted with respect to the main body portion by way of intermediate structure(s), e.g., for purposes of reaching anatomical locations that may otherwise be difficult to reach.
Petals/fingers 20 are also joined to main body portion 16 at proximal junction region 28. In the exemplary embodiment of
Thus, the disclosed introducer 10 exhibits “tear-away” functionality in that, once the mounting member 26 is mounted with respect to the distal end of a surgical stapler, a proximally-directed force applied to main body portion 16, e.g., by grasping proximal extension arm 14, will overcome the banding of the petals/fingers 20 at distal junction and in the region of mounting member 26. In this way, the plurality of petals/fingers 20 become disengaged from each other and from the distal end of the surgical stapler. Once disengaged from each other and from the surgical stapler, the petals/fingers 20 are free to slide proximally along the exterior of the surgical stapler. In addition, application of a proximally-directed force to the main body portion 16, e.g., to proximal extension arm 14, is generally effective to disengage the mounting mechanism(s) associated with the main body portion 16, e.g., C-shaped brackets 18, from the surgical stapler.
Turning to
As shown in
Once surgical stapler 100 is brought to a desired anatomical location, the user can easily disengage introducer 10 from surgical stapler 100 and withdraw the introducer from the surgical field. In particular, the user disengages introducer 10 from surgical stapler 100 by pulling proximally on main body portion 16 of introducer 10, e.g., by grasping proximal extension arm 14, thereby disengaging mounting member 26 from the stapler cartridge 110, disengaging C-shaped brackets 18 from handle 102, and disengaging the arcuate main body portion 16 overall from the surgical stapler shaft 108. Thus, in toto, the disclosed petals/fingers 20 function to “tear away” from the staple cartridge 110 so as to permit withdrawal from the surgical field. Of note, the angled geometry of proximal extension arm 14 facilitates ready access to and grasping thereof by a user when disengagement of introducer 10 from stapler 100 is desired.
The disclosed introducer offers significant advantages for introducing and positioning surgical staplers in a desired anatomical location. In addition, the disclosed introducer is designed such that modifications to conventional surgical staplers are unnecessary to gain the clinical benefits associated therewith. Indeed, the disclosed introducer is susceptible to widespread adoption and use, thereby overcoming a fundamental issue encountered in many surgical applications, namely reliable introduction and positioning of the surgical stapler despite potential irregularities and/or anomalies in a patient's anatomy.
Although the present disclosure has been described with reference to exemplary embodiments and implementations thereof, it is to be understood that the present disclosure is not limited by or to such exemplary embodiments and/or implementations. Rather, the present disclosure is susceptible to various modifications, variations and/or enhancements without departing from the spirit and/or scope of the present disclosure. Thus, the present disclosure expressly encompasses such potential modifications, variations and/or enhancements, as will become apparent to persons of skill in the art from the present disclosure.
Claims
1. An introducer assembly for use with a surgical stapler, comprising:
- a. an elongated main body portion;
- b. one or more mounting mechanisms connected with respect to the elongated main body portion, said one or more mounting mechanisms being configured and dimensioned for detachably mounting with respect to the surgical stapler;
- c. a plurality of petals or fingers defining a distal junction and a mounting member that extends proximally relative to the distal junction and is configured and dimensioned to detachably engage a distal portion of the surgical stapler,
- wherein the plurality of petals or fingers are positioned at least in part radially outward of the proximally extending mounting member so as to define a space between the plurality of petals or fingers and the proximally extending mounting member; and
- wherein the plurality of petals or fingers extend proximally relative to the distal junction and detachably engage the elongated main body portion.
2. The introducer assembly of claim 1, wherein the elongated main body portion defines a proximal extension arm that is angled with respect to a distal extent of the elongated main body portion.
3. The introducer assembly of claim 1, wherein the elongated main body portion defines a substantially arcuate geometry.
4. The introducer assembly of claim 3, wherein the substantially arcuate geometry extends over an arc of about 120° to about 180°.
5. The introducer assembly of claim 1, wherein the elongated main body portion flares out to define a junction region, and wherein the plurality of petals or fingers are detachably engaged to the elongated main body portion in the junction region.
6. The introducer assembly of claim 5, wherein the junction region includes a plurality of circumferentially spaced slots through which the plurality of petals or fingers are joined.
7. The introducer assembly of claim 1, wherein the plurality of petals or fingers define an inner region that is configured and dimensioned to accommodate a distal end of the surgical stapler.
8. The introducer assembly of claim 1, wherein the plurality of petals or fingers are detachably joined with respect to each other at the distal junction.
9. The introducer assembly of claim 1, wherein the proximally-extending mounting member defines either (i) a central channel for receipt of a distally-directed shaft member extending from the surgical stapler, or (ii) a rod-like structure for receipt in a distally-directed channel associated with the surgical stapler.
10. The introducer assembly of claim 1, wherein the distal junction and the proximally-extending mounting member associated with the plurality of petals or fingers are adapted to disengage upon application of a requisite proximally-directed force to the elongated main body portion.
11. In combination:
- a. a surgical stapler that includes a handle, a shaft and a distally positioned stapling member;
- b. an introducer assembly including (i) an elongated main body portion, (ii) one or more mounting mechanisms connected with respect to the elongated main body portion; and (iii) a plurality of petals or fingers positioned at a distal end of the elongated main body portion; wherein said one or more mounting mechanisms are detachably mounted with respect to the surgical stapler, wherein said plurality of petals or fingers define a distal junction and a mounting member that extends proximally relative to the distal junction and are detachably engaged with respect to a distal portion of the surgical stapler, and wherein the plurality of petals or fingers are positioned at least in part radially outward of the proximally extending mounting member so as to define a space between the plurality of petals or fingers and the proximally extending mounting member, and wherein the plurality of petals or fingers extend proximally relative to the distal junction and detachably engage the elongated main body portion.
12. The combination of claim 11, wherein the plurality of petals or fingers associated with the introducer define an inner region that is configured and dimensioned to accommodate a distal end of the surgical stapler.
13. The combination of claim 11, wherein the plurality of petals or fingers are detachably joined with respect to each other at the distal junction.
14. The combination of claim 11, wherein the proximally-extending mounting member defines either (i) a central channel for receipt of a distally-directed shaft member extending from the surgical stapler, or (ii) a rod-like structure for receipt in a distally-directed channel associated with the surgical stapler.
15. The combination of claim 11, wherein the distal junction and the proximally-extending mounting member associated with the plurality of petals or fingers are adapted to disengage upon application of a requisite proximally-extending force to the elongated main body portion.
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Type: Grant
Filed: Apr 8, 2010
Date of Patent: Mar 4, 2014
Patent Publication Number: 20110248067
Inventor: Hidehisa Thomas Takei (Riverside, CA)
Primary Examiner: Robert Long
Application Number: 12/756,713
International Classification: A61B 17/10 (20060101); A61B 17/04 (20060101);